The U.S. Food and Drug Administration recently announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride or fluoride rinses, the products are swallowed and ingested by infants and toddlers. The FDA states that such products have never been approved by the FDA.
Ingested fluoride has been shown to alter the gut microbiome during childhood. Other studies have suggested an association between fluoride and thyroid disorders, weight gain and, possibly, decreased IQ.
“The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” said Marty Makary, FDA commissioner. “I am instructing our center for drug evaluation and research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety.”
The FDA has set a goal date of Oct. 31 for completing a safety review and public comment period and for taking appropriate action regarding the removal of the products from the market. In conjunction with the evaluation, the U.S. Department of Health and Human Services plans to disseminate best practices for dental hygiene in children that are feasible, effective and do not alter gut health.
“Ending the use of ingestible fluoride is long overdue,” said Robert F. Kennedy Jr., HHS secretary. “I’m grateful to Commissioner Makary for his leadership on this vital issue — one that directly safeguards the health and development of our children. This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”
Several states have taken action to stop fluoridation of drinking water. A bill was introduced to repeal the statewide fluoridation program and remove the mandate for water systems to maintain a fluoride content in Arkansas during the most recent legislative session, but the bill died in committee. Fluoride is not added to drinking water in most European countries.
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